{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-28", "results": { "skip": 0, "limit": 1, "total": 93860 } }, "results": [ { "safetyreportversion": "3", "safetyreportid": "10003307", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20151125", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20150812", "fulfillexpeditecriteria": "2", "companynumb": "US-GILEAD-2012-0058057", "duplicate": "1", "reportduplicate": { "duplicatesource": "GILEAD", "duplicatenumb": "US-GILEAD-2012-0058057" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "65", "patientonsetageunit": "801", "patientagegroup": "6", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "Rhinorrhoea", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "LETAIRIS", "drugauthorizationnumb": "022081", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugdosagetext": "10 MG, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "PULMONARY HYPERTENSION", "drugstartdateformat": "102", "drugstartdate": "20110510", "actiondrug": "4", "activesubstance": { "activesubstancename": "AMBRISENTAN" }, "openfda": { "application_number": [ "NDA022081" ], "brand_name": [ "LETAIRIS" ], "generic_name": [ "AMBRISENTAN" ], "manufacturer_name": [ "Gilead Sciences, Inc." ], "product_ndc": [ "61958-0801", "61958-0802" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AMBRISENTAN" ], "rxcui": [ "722116", "722120", "722122", "722124" ], "spl_id": [ "273ba426-0edb-47a2-b5d3-883cd1b9369a" ], "spl_set_id": [ "725d4e73-6c83-477a-adc6-0ae4a133a844" ], "package_ndc": [ "61958-0801-2", "61958-0801-3", "61958-0801-1", "61958-0801-5", "61958-0801-4", "61958-0801-6", "61958-0802-2", "61958-0802-3", "61958-0802-1", "61958-0802-5" ], "nui": [ "N0000175581", "N0000175364" ], "pharm_class_epc": [ "Endothelin Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "Endothelin Receptor Antagonists [MoA]" ], "unii": [ "HW6NV07QEC" ] } }, { "drugcharacterization": "2", "medicinalproduct": "OXYGEN.", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "OXYGEN" }, "openfda": { "brand_name": [ "OXYGEN COMPRESSED U.S.P", "OXYGEN REFRIGERATED LIQUID U.S.P", "OXYGEN", "MEDICAL OXYGEN COMPRESSED", "OXYGEN COMPRESSED GAS", "OXYGEN SIZE B", "OXYGEN SIZE C", "OXYGEN SIZE D", "OXYGEN SIZE E", "OXYGEN SIZE M", "OXYGEN SIZE F", "OXYGEN SIZE H", "OXYGEN SIZE T", "OXYGEN SIZE 400", "OXYGEN REFRIGERATED LIQUID", "MEDICAL GASSEOUS OXYGEN CYLINDERS", "OXYGEN COMPRESSED UN 1072 REFRIGERATED UN 1073", "MEDICAL AIR", "OXYGEN 64889-0001", "OXYGEN, COMPRESSED GAS" ], "generic_name": [ "OXYGEN", "0XYGEN" ], "manufacturer_name": [ "Apria Healthcare LLC", "AGL Inhalation Therapy Co.", "MMC - Dickinson Home Medical Equipment", "New Bedford Welding Supply, Inc.", "Johnson Medical Consulting, Inc dba Combined Home Medical Equipment", "Calox Inc", "O2 for U, Inc.", "Linde Puerto Rico B.V.", "Superior Oxygen & Medical Equipment", "Indiana Oxygen Company Inc", "General Cryogenic Technologies LLC", "MedCyl Services, Ltd.", "Gilmore Liquid Air Co.", "Dick's Home Care, Inc dba Dick's Homecare, Inc.", "Plains Welding Supply, Inc.", "Anesthesia Service, Inc.", "ACUTE CARE GAS LLC", "Home Medical Equipment Specialists, LLC", "UCG Georgia, LLC", "Baird Respiratory Therapy, Inc.", "GenVentures, Inc dba MercyOne Genesis Kimberly Road Home Medical Equipment", "Westair Gases & Equipment, Inc.", "Texas Medical, Inc.", "P and J Oxyfill, LLC", "Air Source Industries Inc", "Community Surgical Supply of Toms River LLC", "Browning's Pharmacy and Health Care Inc.", "Hometown Medical LLC", "Mid-Cities Home Medical Delivery Service L L C", "Bronx Welding Supply Inc", "At Home Medical, Inc.", "Richmond Oxygen Company Inc.", "Raimy Corporation", "All Saints Home Medical", "Roberts Oxygen Company, Inc.", "HARTMAN BROTHERS, INC.", "ADF Welding & Medical, Inc.", "EUGENE WELDERS SUPPLY CO", "American Compressed Gases Inc.", "S & S Drug Inc.", "Air Products and Chemicals, Inc.", "Seventh Street Medical Supply, Inc", "Diamond Drugs Inc. dba Diamond Medical Supply", "I.D.M. 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"CONNECTIVE TISSUE DISORDER", "actiondrug": "4", "activesubstance": { "activesubstancename": "AMBRISENTAN" }, "openfda": { "application_number": [ "NDA022081" ], "brand_name": [ "LETAIRIS" ], "generic_name": [ "AMBRISENTAN" ], "manufacturer_name": [ "Gilead Sciences, Inc." ], "product_ndc": [ "61958-0801", "61958-0802" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AMBRISENTAN" ], "rxcui": [ "722116", "722120", "722122", "722124" ], "spl_id": [ "273ba426-0edb-47a2-b5d3-883cd1b9369a" ], "spl_set_id": [ "725d4e73-6c83-477a-adc6-0ae4a133a844" ], "package_ndc": [ "61958-0801-2", "61958-0801-3", "61958-0801-1", "61958-0801-5", "61958-0801-4", "61958-0801-6", "61958-0802-2", "61958-0802-3", "61958-0802-1", "61958-0802-5" ], "nui": [ "N0000175581", "N0000175364" ], "pharm_class_epc": [ "Endothelin Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "Endothelin Receptor Antagonists [MoA]" ], "unii": [ "HW6NV07QEC" ] } } ] } } ] }